Screening for Atherotic Plaques by Ultrasound for Assessing Cardiovascular Risk

Completed

• Conditions: Atherosclerosis of Artery

• Registration Number: NCT03499496
• Lead Sponsor: Cabinet de Medecine Interne Générale Demetrio Pitarch

Brief Summary

Cardiovascular disease is a common diagnosed and treated condition in private practices of primary health care. There is growing evidence that atherosclerotic plaques as predictors for stroke and heart attack are more prevalent than expected based on the clinical score in people with low risk for stroke and heart attack .

Diagnosing atherosclerotic plaques can help to decide if a lipid lowering therapy should be prescribed even if the clinical risk score is low or on the other hand if they can be observed even in high lipid levels.

Detailed Description

Both common and proximal internal carotid arteries and both common femoral arteries (including bifurcations) were screened by ultrasound in patients who came for a check-up to a primary care practice with no known cardiovascular disease and low risk for stroke and heart attack according to the AGLA/GSLA risk score which is mostly used in Switzerland.

All patients agreed and gave written informed consent to be included in this study. Presence of plaques was defined as a focal carotid intima-media thickness \>0.5 cm on ultrasound. Screening was performed by a medical doctor (DP) certified for the procedure using the following ultrasound system: Toshiba Nemio XG, probe 7.5 MhZ.

Study Timeline

• Study Start: 2016-01-15
• Primary Completion: 2016-08-30
• Study Completion: 2016-09-04
• Study First Submitted: 2018-03-22
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-09
• Last Update Submitted: 2018-04-09
• Study First Posted: 2018-04-17
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• low cardiovascular risk assessed by the AGLA/GSLA-score

Exclusion Criteria

• cardiovascular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of plaques in cardiovascular low risk population	1 year	Number of participants with the presence of carotid and/or femoral atherosclerotic plaques diagnosed via ultrasound (defined as a focal intima-media thickness \>0.5 cm on ultrasound).